Long-term renal safety of tenofovir disoproxil fumarate in antiretroviral-naïve HIV-1-infected patients. Data from a double-blind randomized active-controlled multicentre study

Hassane Izzedine, Jean Sebastien Hulot, Daniel Vittecoq, Joel E. Gallant, Schlomo Staszewski, Vincent Launay-Vacher, Andrew Cheng, Gilbert Deray

Research output: Contribution to journalArticlepeer-review

Abstract

Background. Tenofovir disoproxil fumarate (TDF) was developed for the treatment of human immunodeficiency virus (HIV) infection. However, controlled data are sparse on the long-term renal tolerability of TDF at the currently approved daily dose of 300 mg in treatment-naive HIV-infected patients. Methods. Over 144 weeks, this 600 patient, multicentre randomized, placebo-controlled, double-blind trial compared stavudine (301 patients) and TDF (299 patients), both administered in combination with lamivudine and efavirenz, in antiretroviral-naïve patients. TDF or placebo and stavudine or placebo were administered in an open-label fashion. All medications were taken orally. At screening, all patients had serum creatinines 6 mg/dl) serum creatinine elevations. At week 144, there was no change from baseline in the mean (0.83 mg/dl) serum creatinine in the TDF group compared with a 0.1 mg/dl decrease from baseline (0.83 mg/dl) in the stavudine control group. The incidences of grades 1 (2.0-2.2 mg/dl), 2 (1.5-1.9 mg/dl) and 3 (1.0-1.4 mg/dl) hypophosphataemia at week 144 were 4, 3 and

Original languageEnglish (US)
Pages (from-to)743-746
Number of pages4
JournalNephrology Dialysis Transplantation
Volume20
Issue number4
DOIs
StatePublished - Apr 2005

Keywords

  • Long-term renal safety
  • Tenofovir
  • Tubulopathy

ASJC Scopus subject areas

  • Nephrology
  • Transplantation

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